Medication info

GL Estradiol Valerate Tablet

Prescription medication경구Approval withdrawn
Ingredient · strength
Estradiol Valerate›2mg / 1 tablet
Manufacturer / importer
지엘파마(주)
Appearance
A blue to light blue, round, biconvex sugar-coated tablet
Packaging
28 tablets/PTP [28 tablets/PTP x 1]
Approval status
Approval withdrawn

MFDS item code 202300247 · Notified 2023.01.13

This product's status changed to Approval withdrawn on 2024.04.26. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Relief of menopausal symptoms and prevention of osteoporosis
Who takes it
Adults · Children
Adult dose
As estradiol valerate, take 1 mg or 2 mg orally after meals once daily. Continue the treatment and immediately take the next new pack without interruption. Adjust the dose appropriately depending on the course of treatment. Swallow the tablet whole with an appropriate beverage, preferably taking it at the same time each day.
Child dose
This medication is not used in children and adolescents.

Ingredients

Manufacturer
지엘파마(주)

Efficacy & effects

Relief of menopausal symptoms and prevention of osteoporosis

  • Menopausal symptoms
  • osteoporosis
View approved original text

This medication is used to relieve menopausal symptoms in postmenopausal women and to prevent osteoporosis in women at high risk for fractures. Women with a uterus must take a progestogen for 12 days each month, so it is important to strictly follow the treatment plan. This therapy helps maintain women's health and effectively improve symptoms.

How to take

Adult dose

As estradiol valerate, take 1 mg or 2 mg orally after meals once daily. Continue the treatment and immediately take the next new pack without interruption. Adjust the dose appropriately depending on the course of treatment. Swallow the tablet whole with an appropriate beverage, preferably taking it at the same time each day.

Child dose

This medication is not used in children and adolescents.

Precautions

This medication may increase the risk of endometrial cancer in postmenopausal women; therefore, women with a uterus should take additional medications as directed by a physician. There is a risk of developing serious vascular diseases such as thrombosis during treatment. If there are risk factors, consultation with a doctor and careful monitoring are essential. If severe headaches or migraines develop suddenly or occur frequently, stop taking the medication and inform a doctor. If sudden vision disturbances or symptoms of thrombosis occur, stop taking the medication immediately. If liver dysfunction, jaundice, elevated blood pressure, or increased seizures occur, the medication must also be discontinued. Women who are pregnant or may become pregnant, or breastfeeding mothers should not take this medication. This drug should not be administered to patients with certain diseases or medical histories, especially those with thrombosis, endometrial cancer, breast cancer, or liver disease. Regular physical and gynecological exams should be conducted during treatment, and consistent examinations are needed to reduce the risk of breast and endometrial cancer. Long-term use may slightly increase the risk of breast and ovarian cancer, making regular screenings important. This medication may affect liver function, so patients with liver disease should have periodic liver function tests. It may interact with other medications, so inform a doctor or pharmacist if taking any other drugs. Diabetic patients should be carefully monitored as blood sugar control may be affected. In case of overdose, symptoms may include breast tenderness, abdominal bloating, anxiety, and nausea, but these typically improve with dosage adjustment. This medication should be kept out of the reach of children and stored in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor
  • Severe rash with fever, blisters, skin peeling, pain in mouth/eyes
  • Shortness of breath or difficulty breathing, asthma attacks, abnormal breathing with coughing and fever
  • Yellowing of the skin or eyes (jaundice), extreme fatigue
  • Sudden and very severe headaches, lightning-like headaches, seizures, confusion, visual disturbances, paralysis
  • Significantly reduced urine output

Mild side effects

Weight gain or loss, depressed mood, anxiety, decreased or increased libido, headache, dizziness, migraine, intolerance to contact lenses, palpitations, abdominal pain, nausea, indigestion, abdominal bloating, vomiting, rash, itching, nodular erythema, hirsutism, acne, muscle cramps, pinpoint bleeding including uterine/vaginal bleeding, breast pain, breast tenderness, menstrual pain, vaginal discharge, premenstrual syndrome, increased breast size, edema, fatigue

Not everyone experiences these, and they can vary from person to person.

Storage

This medication is susceptible to air or moisture, so it should be stored in a sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

A blue to light blue, round, biconvex sugar-coated tablet

Package unit

28 tablets/PTP [28 tablets/PTP x 1]

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.